CPI Cheat Sheet 2026

The 30 highest-yield CPI facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Why is it important for investigators to report adverse events? → To ensure patient safety and make necessary adjustments
2. The principle of 'justice' in the Belmont Report specifically addresses which research concern? → Fair distribution of research benefits and burdens across populations
3. What is the purpose of randomization codes or the randomization list in a clinical trial? → To assign subjects to treatment arms in an unpredictable manner to minimize selection bias
4. Which element is NOT required in a federally compliant informed consent document under 21 CFR Part 50? → Guarantee that the participant will receive the experimental treatment
5. A clinical investigator must ensure that all CRF data can be traced back to source documents. This principle is known as: → Source data traceability
6. What is a statistical test used for in clinical research? → To assess if findings are significant and generalizable
7. What is a clinical endpoint? → A measure used to assess the outcome of treatment
8. In a dose-response relationship, what does a monotonic response pattern indicate? → The effect consistently increases or decreases with increasing dose without reversals
9. A participant in an oncology trial develops febrile neutropenia. Which infection control measure is MOST critical to implement immediately? → Protective (Reverse) Isolation
10. Under 45 CFR Part 46, research that qualifies for exemption under Category 1 involves which type of participants? → Normal educational practices in established educational settings
11. During a clinical trial, which of the following would constitute a breach of aseptic technique when preparing an injectable investigational product? → Preparing the product outside a biological safety cabinet
12. What is scope creep in CPI project management? → Uncontrolled scope expansion without adjusting time, cost, or resources
13. What is a near-miss report in CPI practice? → Documentation of an event that could have caused harm but did not
14. A protocol specifies 'stratified randomization' by disease severity. What is the PRIMARY advantage of this approach over simple randomization? → It ensures balance of key prognostic factors across treatment arms
15. Who is primarily responsible for reporting SAEs to the clinical trial sponsor? → The principal investigator or sub-investigator at the site
16. Protocol amendments that change study procedures must be reflected in the source documents by: → Documenting the amendment approval date and updating procedures in subsequent visit notes
17. The Columbia Suicide Severity Rating Scale (C-SSRS) is used in clinical trials primarily to: → Systematically evaluate suicidal ideation and behavior as a safety endpoint
18. What is evidence-based practice in CPI Pharmacology & Medication Management? → Integrating research evidence with expertise and client needs
19. A meta-analysis that pools data from individual patient records rather than published summary statistics is called a: → Individual patient data (IPD) meta-analysis
20. ICH E6(R2) Good Clinical Practice guidelines require that the investigator ensure all study personnel have which of the following? → Adequate training for their assigned clinical trial tasks
21. What does residual risk mean in CPI practice? → Risk remaining after all controls are implemented
22. At what reading level should informed consent documents ideally be written, per FDA and OHRP guidance? → 8th grade or below
23. A participant in a blinded clinical trial requires emergency surgery and the surgeon needs to know the study drug. What is the correct action? → Use the emergency unblinding procedure to reveal the participant's treatment assignment
24. Under ICH E6(R2) guidelines, what is the principal investigator's responsibility when a serious adverse event (SAE) occurs in a clinical trial? → Notify the sponsor immediately and complete required documentation
25. A researcher notices that trial staff are not consistently performing hand hygiene between participant contacts. The MOST effective immediate intervention is: → Install alcohol-based hand rub dispensers at point-of-care
26. Which of the following best describes the Hawthorne effect in clinical research? → Participants improve outcomes simply because they know they are being observed
27. In a multi-site clinical trial, one site reports an unusually high rate of surgical site infections (SSIs). The FIRST step in investigation should be: → Conduct a root cause analysis of aseptic technique and processes
28. What is a records management audit in CPI? → Reviewing practices to ensure compliance with policies
29. What is a needs assessment in CPI Infection Control & Prevention practice? → Identifying gaps between current conditions and desired outcomes
30. What is the role of the FDA in clinical trials? → To ensure safety and approval of new drugs